Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL

NCT06470451 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: HPN-CTCL-03-EUR
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 17

Brief Summary

To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Conditions

CTCL/ Mycosis Fungoides; CTCL; Mycosis Fungoides; Cutaneous T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score

  A treatment response is defined as a ≥50% improvement in the cumulative mCAILS score of the index lesions at Week 18 when compared to the mCAILS score at baseline. The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome.

  18 weeks

Secondary Outcomes (2)

• Patch Lesion Response Rates

  18 weeks

• Plaque Lesion Response Rates

  18 weeks

Study Arms (2)

HyBryte (0.25% Hypericin)

EXPERIMENTAL

HyBryte gel is applied twice weekly for 18 weeks.

Drug: Hypericin

Placebo

PLACEBO COMPARATOR

Placebo gel is indistinguishable from HyBryte gel, and is applied twice weekly for 18 weeks.

Drug: Placebo

Interventions

Hypericin DRUG

HyBryte gel (0.25% hypericin) is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.

Also known as: HyBryte, SGX301

HyBryte (0.25% Hypericin)

Placebo DRUG

Placebo gel is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL), Stage IA, Stage IB, or Stage IIA.
• Patients with a minimum of three (3) evaluable, discrete lesions.
• Patients willing to follow the clinical protocol and voluntarily give their written informed consent.
• Female patients not pregnant or nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation.

You may not qualify if:

• History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions, or radiation therapy within 30 days of enrolling.
• History of allergy or hypersensitivity to any of the components of HyBryte.
• A Screening ECG with a QT interval \>470 ms (corrected for heart rate using the Fridericia's formula).
• All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception.
• Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment.
• Patients receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 4 weeks of enrollment.
• Patients who have received electron beam irradiation within 3 months of enrollment.
• Patients with a history of significant systemic immunosuppression.
• Patients taking other investigational drugs or drugs of abuse within 30 days of entry into this study.
• Patients whose condition is spontaneously improving.
• Patients with tumor stage or erythrodermic CTCL (stages IIB-IV).
• Patients with extensive skin disease (\>30% body surface area) who would be, in the judgement of the Principal Investigator, candidates for systemic treatment.
• Patient has any condition that, in the judgment of the PI, is likely to interfere with participation in the study.
• Prior participation in the current study.

Sponsors & Collaborators

• Soligenix: lead

Study Sites (17)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

RECRUITING

Mayo Clinic

Scottsdale, Arizona, 85259, United States

RECRUITING

Therapeutics Clinical Research

San Diego, California, 92123, United States

RECRUITING

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Dawes Fretzin Dermatology Group

Indianapolis, Indiana, 46256, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Rochester Skin Lymphoma Medical Group

Fairport, New York, 14450, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

COMPLETED

Accellacare (PMG)

Wilmington, North Carolina, 28411, United States

COMPLETED

Penn State Health Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37212, United States

RECRUITING

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous

Interventions

hypericin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jennifer Bonfrisco

CONTACT

609-538-8200; jbonfrisco@soligenix.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)